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Erschienen in:
24.07.2015 | Original Article
Phase I study of concurrent vinorelbine and radiation therapy in high-risk postmastectomy breast cancer patients
Erschienen in: Breast Cancer | Ausgabe 5/2016
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Background
Postmastectomy chest wall irradiation is recommended for high-risk breast cancer patients, such as those with ≥4 positive nodes. Irradiation is performed sequentially rather than concurrently with chemotherapy. However, the 5-year locoregional recurrence-free survival was statistically better in the concurrent method in node-positive patients in a prior study. The benefit of concurrent chemoradiotherapy for postmastectomy breast cancer patients is uncertain. Vinorelbine is often used as concurrent chemoradiotherapy for non-small cell lung cancer in Japan and has antitumor activity in breast cancer as well. Thus, we planned this dose-finding study of concurrent vinorelbine and radiation therapy in high-risk postmastectomy breast cancer patients.
Methods
High-risk postmastectomy breast cancer patients were recruited. Patients received weekly vinorelbine administered concurrently with radiation therapy. The radiation dose was 50 Gy in 25 fractions over 5 weeks. Vinorelbine was administered weekly without a break, so the maximum number of vinorelbine cycles was five. A 3 + 3 dose-escalation design was used for determining maximal tolerable dose, recommended dose and safety.
Results
A total of 10 patients were enrolled in cohorts of 10 and 15 mg/m2. Dose-limiting toxicity was observed in one case in 10 mg/m2 and two cases in 15 mg/m2. Therefore, the maximal tolerable dose was defined at 15 mg/m2 and the recommended dose was determined at 10 mg/m2. The main adverse events included radiation dermatitis and neutropenia. Recurrence was observed in one patient with a median follow-up of 40 months.
Conclusions
Concurrent vinorelbine and radiation therapy has a manageable safety profile at 10 mg/m2 in high-risk postmastectomy breast cancer patients.